Treats chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sold as Imbruvica. Every FDA application for this active ingredient: 3 branded and 8 generic.
As of Nov 13, 2026, FDA lists 11 applications for Ibrutinib (sold as Imbruvica), first approved Feb 12, 2014, with 24 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Imbruvica | Part D | $2.36B | +4% | 14,773 |
| MACE and BTK InhibitorsHematologic Cancer, MACE · University Hospital, Caen | Phase 4 | Not yet recruiting | Nov 6, 2026 |
| Prophylactic Strategies for Mitigating Central Nervous System Relapse in Diffuse Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma (DLBCL) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 | Not yet recruiting | Nov 4, 2026 |
| Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)Waldenstrom Macroglobulinemia · National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 | Not yet recruiting | Oct 20, 2026 |
| Ibrutinib Plus Venetoclax Long-Term Outcomes in CLLChronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) · European Research Initiative on CLL | — | Recruiting | Aug 19, 2026 |
| Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 AlterationsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma · The Lymphoma Academic Research Organisation | Phase 2 | Not yet recruiting | Jul 31, 2026 |
| Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor TherapyAtrial Fibrillation (AF), Chronic Lymphocytic Leukemia · Tina Baykaner | — | Not yet recruiting | Jul 17, 2026 |
| A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell · Janssen Research & Development, LLC | — | Recruiting | May 22, 2026 |
| BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.Waldenstrom Macroglobulinaemia, Multiple Myeloma · Anne Louise Tølbøll Sørensen | Phase 4 | Not yet recruiting | Mar 16, 2026 |
| Feb 12, 2014 | ImbruvicaNDA 205552 · Efficacy (new indication or use) | Pharmacyclics LLC | 35 | Marketed |
| Feb 16, 2018 | ImbruvicaNDA 210563 · Efficacy (new indication or use) | Pharmacyclics LLC | 16 | Marketed |
| Mar 31, 2021 | IbrutinibANDA 211344 | Zydus Lifesciences | 1 | Discontinued |
| Aug 24, 2022 | ImbruvicaNDA 217003 · New formulation or manufacturer | Pharmacyclics LLC | 4 | Marketed |
| Sep 8, 2026 | IbrutinibANDA 211182 | Hetero Labs Ltd V | 0 | Marketed |
| — | IbrutinibANDA 211267 | Sandoz Inc | 0 | Discontinued |
| — | IbrutinibANDA 211350 | Teva Pharms USA Inc | 0 | Discontinued |
| — | IbrutinibANDA 212763 | Alvogen Pine Brook | 0 | Discontinued |
| — | IbrutinibANDA 214296 | Zydus Worldwide Dmcc | 0 | Discontinued |
| — | IbrutinibANDA 214498 | Alvogen Inc | 0 | Discontinued |
| — | IbrutinibANDA 215464 | Sandoz Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Zydus Lifesciences